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Association of Facial Paralysis With mRNA COVID-19 VaccinesA Disproportionality Analysis Using the World Health Organization Pharmacovigilance Database

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To identify the key insights or developments described in this article
1 Credit CME

During the pivotal phase 3 clinical trials of mRNA COVID-19 vaccines, several cases of facial paralysis were observed in the vaccine groups (7 of 35 654) compared with 1 case among people who received placebo (1 of 35 611).1,2 Although a causal relationship could not be established from clinical trials, the US Food and Drug Administration recommended monitoring vaccine recipients for facial paralysis. We thus explored this potential safety signal through a disproportionality analysis using the World Health Organization pharmacovigilance database, VigiBase.

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Article Information

Accepted for Publication: March 31, 2021.

Published Online: April 27, 2021. doi:10.1001/jamainternmed.2021.2219

Corresponding Author: Charles Khouri, PharmD, Pharmacovigilance Department, University Grenoble Alpes and Grenoble Alpes University Hospital, Centre Regional de Pharmacovigilance, CHU Grenoble Alpes, CS 10217, 38043 Grenoble Cedex 9, France (ckhouri@chu-grenoble.fr).

Author Contributions: Dr Khouri had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Mr Renoud and Dr Khouri served as co–first authors.

Concept and design: Khouri, Revol, Perez, Cracowski.

Acquisition, analysis, or interpretation of data: Renoud, Khouri, Lepelley, Roustit, Cracowski.

Drafting of the manuscript: Renoud, Khouri.

Critical revision of the manuscript for important intellectual content: Khouri, Revol, Lepelley, Perez, Roustit, Cracowski.

Statistical analysis: Renoud, Khouri, Revol, Perez.

Administrative, technical, or material support: Renoud.

Supervision: Khouri, Lepelley, Cracowski.

Conflict of Interest Disclosures: None reported.

Disclaimer: The information does not represent the opinions of the Uppsala Monitoring Centre or the World Health Organization.

Additional Information: We thank VigiBase for giving us access to the data. The data supplied to VigiBase come from a variety of sources, and the likelihood of a causal relationship is not the same in all reports.

References
1.
Polack  FP , Thomas  SJ , Kitchin  N ,  et al; C4591001 Clinical Trial Group.  Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine.   N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577 PubMedGoogle ScholarCrossref
2.
Baden  LR , El Sahly  HM , Essink  B ,  et al; COVE Study Group.  Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine.   N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389 PubMedGoogle ScholarCrossref
3.
Bate  A , Lindquist  M , Edwards  IR ,  et al.  A Bayesian neural network method for adverse drug reaction signal generation.   Eur J Clin Pharmacol. 1998;54(4):315-321. doi:10.1007/s002280050466 PubMedGoogle ScholarCrossref
4.
Holland  NJ , Bernstein  JM .  Bell’s palsy.   BMJ Clin Evid. 2014;2014:1204.PubMedGoogle Scholar
5.
Kamath  A , Maity  N , Nayak  MA .  Facial paralysis following influenza vaccination: a disproportionality analysis using the Vaccine Adverse Event Reporting System Database.   Clin Drug Investig. 2020;40(9):883-889. doi:10.1007/s40261-020-00952-0PubMedGoogle ScholarCrossref
6.
Rowhani-Rahbar  A , Klein  NP , Lewis  N ,  et al.  Immunization and Bell’s palsy in children: a case-centered analysis.   Am J Epidemiol. 2012;175(9):878-885. doi:10.1093/aje/kws011 PubMedGoogle ScholarCrossref
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